Evaluation of MicroRNAs and Vitamin B12 Expression in Subjects with Neurologic Symptoms of Depression, Anxiety and Fatigue in Long COVID-19

March 5, 2025 updated by: Alfonso B. Alfaro, Instituto Nacional de Rehabilitacion

At the moment, the number of people with long COVID is unkown because there is still no effective diagnosis. This is why is very important to analyze the most common symptoms, which are: depression, anxiety and fatigue. This project seeks to analyze some blood components of people with long COVID, such as microRNAs and vitamin B12, in order to identify the body processes that changed after COVID-19 and thereby design better therapies and diagnostic methods focused on each of them.

The hypothesis is that the expression of miR-21, -146a and -155 will be overexpressed as well as there will be a deficiency of vitamin B12 in serum in subjects suffering from long COVID with neurological symptoms of depression, anxiety and fatigue.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Ciudad de México, Mexico, 14389
        • Recruiting
        • Instituto Nacional De Rehabilitacion
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects with symptoms of depression, anxiety and fatigue after having had COVID-19

Description

Inclusion Criteria:

  • Subjects with confirmed diagnosis of COVID-19 by SARS-CoV-2 infection by PCR or antigen testing.
  • With presence of neurological symptoms of depression, anxiety and fatigue associated with COVID-19 after three months from the first day of acute infection symptoms.

Exclusion Criteria:

  • Subjects who have presented symptoms of acute infection in the last twelve weeks.
  • Subjects who present diagnostic premorbid neurological alterations.
  • Subjects who do not have at least 2 doses of COVID-19 vaccine, with last application date equal or older than 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Long COVID
With presence of neurological symptoms of depression, anxiety and fatigue associated with COVID-19 three months after the first day with symptoms of acute infection
Control
Not presented symptoms associated with COVID-19 twelve weeks after the first day with symptoms of acute infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of microRNA expression between long COVID group and control group
Time Frame: immediately after the blood extraction
immediately after the blood extraction
Change of vitamin B12 concentration between long COVID group and control group
Time Frame: immediately after the blood extraction
immediately after the blood extraction
Link the expression of microRNAs with the score obtained in the instruments to evaluate depression, anxiety and fatigue
Time Frame: immediately after the blood extraction
immediately after the blood extraction
Link the concentration of vitamin B23 with the score obtained in the instruments to evaluate depression, anxiety and fatigue.
Time Frame: immediately after the blood extraction
immediately after the blood extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Rehabilitacion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03/24 AD 2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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